ACTIVA
Report
- Report Number
- 3004209178-2012-06313
- Event Type
- Malfunction
- Date Received
- July 31, 2012
- Report Date
- July 3, 2012
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
PRODUCT ID 7482A66, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 7482A66, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT# V021585, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT# V021585, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD. (B)(4).
IT WAS REPORTED THAT THERE WERE ISSUES REGARDING DEVICE IMPEDANCE. AFTER THE DEVICE WAS CHANGED OUT DUE TO NORMAL BATTERY DEPLETION, HIGH IMPEDANCES WERE FOUND. IT WAS REVIEWED THE POSSIBILITY OF AN OPEN CIRCUIT. C,4-4,5-4,6-4,7 ALL >40K; C,5-C,6-C,7 ALL AROUND 1000; 5 ,6=1200; 5,7=1500; 6,7=1300; C,2 = 13564; 0,2=14121; 1,2=13745; 2,3=13161; 0,1=1000; 0,3=1400; C,1=800; 1,3=1100; C,3=742. IT WAS PROGRAMMED AT 6-5+4- AND DISCUSSED TAKING THE 4- OFF. IT ALSO WAS PROGRAMMED AT 3+2-1+0- AND DISCUSSED TAKING THE 2- OFF. THE PATIENT WAS GETTING GOOD THERAPY CONTROL BEFORE SURGERY AND IT WAS ANTICIPATED TO BE THE SAME AFTER SURGERY. ADDITIONAL INFORMATION REPORTED THE HIGH IMPEDANCE MEASUREMENTS WERE UNDETERMINED. THE PHYSICIAN WAS GOING TO TRY AND PROGRAM AROUND THE POSSIBLE OPENS. THE PATIENT CLAIMED TO BE RECEIVING THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |